Integra LifeSciences Corp.: CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrosp

Hazard

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.

Details from the source

Reason for recall: Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility. Distribution: Worldwide - US Nationwide distribution in the state of TX and the countries of Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of China), Turkey Quantity: 135 units Lot/code info: UDI-DI: 10381780515593 Lot numbers: 7320001, 7320004, 720005, 7322926, 322927

UPC codes

10381780515593

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.